Phase 1/2 Multicenter Study Evaluating the Safety and Efficacy of KTE-X19 in Adult Subjects with Relapsed/Refractory Chronic Lymphocytic Leukemia - ZUMA-8

KITE PHARMA INC.0 sites108 target enrollmentJune 17, 2021

Overview

No summary available.

Registry

who.int

Start Date

June 17, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•1\. Documentation of relapsed or refractory CLL; subjects must have received at least 2 prior lines of treatment, one of which must include a BTK inhibitor
•2\. An indication for treatment per IWCLL 2018 criteria and radiographically measurable disease (at least 1 lesion \> 1\.5cm in diameter)
•3\. Adequate hematologic function
•4\. Adequate renal, hepatic, cardiac and pulmonary function
•5\. Age 18 or older
•6\. ECOG performance status of 0 or 1
•7\. Females of childbearing potential must have a negative serum or urine pregnancy test
•8\. At least 2 weeks or 5 half\-lives, whichever is shorter, must have elapsed since any prior systemic therapy or BTKi (ibrutinib or acalabrutinib) at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half\-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4\-1BB agonists)
•Are the trial subjects under 18? no
•Number of subjects for this age range:

•\- A history of treatment including any of the following:
•a. Prior CD19 directed therapy
•b. Treatment with alemtuzumab within 6 months before enrollment
•c. Prior allogeneic hematopoietic stem cell transplant or donor lymphocyte infusion within 6 months prior to enrollment
•d. Live vaccine administration within 4 weeks before enrollment
•e. Systemic immunosuppression or systemic treatment for any autoimmune disease not related to CLL in the 2 years before enrollment
•\- Acute GVHD grade II\-IV by Glucksberg criteria or severity B\-D by IBMTR index
•\- History of autoimmune disease resulting in end\-organ injury unless attributable to CLL (eg, ITP, AIHA)
•\- Diagnosis of Richter’s transformation or a history of malignancy other than non\-melanoma skin cancer or carcinoma in situ (eg, skin, cervix, bladder, breast), superficial bladder cancer, asymptomatic localized low grade prostate cancer for which watch\-and\-wait approach is standard of care, or any other cancer that has been in remission for \> 3 years prior to enrollment
•\- History of severe hypersensitivity reaction attributed to aminoglycosides or any of the agents required for treatment in this study